The purpose

A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150
outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d,
duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and
follow-up visits 1 week and 3 months post-treatment.

Provided treatments

Drug: Pregabalin

Drug: Duloxetine

Behavioral: Standardized behavioral therapy

Behavioral: Standardized behavioral therapy

Drug: Placebo

Behavioral: Standardized behavioral therapy

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Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.

Full eligibility criteria for NCT00929344

Ages eligible for Study

18 Years and older

Genders eligible for Study

All

Accepts Healthy Volunteers

No

Inclusion Criteria:

Males or females 18 years of age

Meets DSM-IV criteria for current alcohol dependence and drinking an average of ≥21 drinks weekly for males, ≥14 females,

Seeking research-based outpatient treatment for alcohol problems

Willing to attend 12 weekly study visits and 2 follow-up visits

Have normal bilirubin, and ALT, AST, and GGT values no more than 3x the ULN, and no evidence of hepatic insufficiency

Exclusion Criteria:

Active suicidal ideation

Medical disorders that will increase potential risk or interfere with study participation

Sexually active female subjects with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control

Males who refuse to use a reliable method of birth control

Meets DSM-IV criteria for any other current major AXIS I disorder other than alcohol or nicotine dependence.

Inability to understand and/or comply with the provisions of the protocol and consent form

Treatment with an antidepressant medication during the two weeks, or fluoxetine during the month, prior to randomization

Ongoing treatment with disulfiram (Antabuse), naltrexone (ReVia), acamprosate
(Campral) or other medications that may affect study outcomes, e.g., anticonvulsants or other drugs that act on serotonin in the brain

Ongoing treatment with drugs that may increase potential risk (Actos),

All locations for NCT00929344

1 locations

United States (1)

The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

La Jolla, California, United States, 92037

Not specified

Trial results for NCT00929344

Participant Flow: Overall Study

Duloxetine

28 / 50

Completed / Started

Pregabalin

37 / 50

Completed / Started

Placebo

29 / 50

Completed / Started

Serious Adverse Events

Duloxetine

2 / 50

Affected / At Risk

Pregabalin

0 / 50

Affected / At Risk

Placebo

4 / 50

Affected / At Risk

Other Adverse Events

Duloxetine

43 / 50

Affected / At Risk

Pregabalin

35 / 50

Affected / At Risk

Placebo

33 / 50

Affected / At Risk

All Locations

View full eligibility

Results

Tris trial is registered with FDA with number: NCT00929344. The sponsor of the trial is The Scripps Research Institute and it is looking for 150 volunteers for the current phase.

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